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Objectives and Responsibilities

Accountable for the Geel site internal audit program and external GMP inspection management (e.g. Health Authority, Customer).

Acting as compliance Subject Matter Expert and deploy compliance initiatives at the Geel site in alignment with the Pharmaceutical Regulatory Compliance strategy.

Coordinate team of Geel-based compliance personnel

Support the compliance teams of Beerse, Geel, Athens and Cork SM to deliver the site internal audit program and external GMP inspection management program.

Responsibilities IMRC Compliance Lead for Geel

• Responsible for site internal audit program including:

• Establish and create schedule

• Auditor training (qualify and evaluate)

• Execute internal audits (schedule, issue agenda, prepare, conduct audit, issue report)

• Execute compliance walk-throughs (e.g. IWR)

• Evaluate responses to internal audits

• Enter internal audit data in Comet

• Maintain site inspection readiness program for external GMP audits and inspections (Health Authority, Customer). Including:

• Facilitate inspection management (front room, back room, coaching)

• Lead the site response efforts including assignment of appropriate CAPAs

• Inspection Readiness (audit preparation, schedule and manage mock inspections, SME coaching)

• Partner with Quality to manage inspections (host and/or coordinate front room and back room, daily inspection summaries)

• Review site response and associated CAPA for Health Authority inspections

• Provide input to daily inspection summaries, as needed

• Identify changes in regulations that impact compliance procedure, perform gap analysis against current practices. Implement J&J Compliance Stds (e.g. Audit/Inspection Mgt) and partner with sites on J&J standard implementation

• Provide Compliance Subject Matter Expertise (SME) for site personnel, Quality Systems and/or projects. As needed, review complaints and field actions.

• Ensure appropriate and timely escalation of risks to the appropriate leadership and regulatory compliance teams. Facilitate remediation of compliance risks

• Represent Regulatory Compliance at Site Management Reviews, CAPA Review Boards, Escalations, Platform Compliance mtgs, etc.

• Partner with site for execution of proactive compliance scans.

• Partner with site and segment personnel (e.g. Regulatory Affairs, Operations, Product Quality Mgt, etc.) to proactively identify risks and drive compliance improvement across the site.

• Establish a high performance and continuous improvement culture driven by key performance metrics, benchmarking and sharing of best practices

• As applicable, report progress of site compliance remediation plans (e.g. MCAP, SDCAP, etc.)

• Collaborate with other groups in IMRC and JJRC to support execution of independent audits and special assessments. Support site during ERC audits (e.g. document review, front/back room support). Review and provide input to site response, and associated CAPA, to ERC audits.

• Coordinate, maintain, report and drive site compliance metrics.

• Establish department policy, standard operations procedures and working practices.

• Coordinate compliance training for the site

• Support Quality and Compliance strategy implementation

• Connect with external groups (e.g. PDA, ISPE, etc.) to benchmark industry standards

• As needed, provide training for Quality concepts and/or systems.

• As needed, co-authors, review and revise compliance procedures.

• As needed, review (not approve) significant manufacturing and laboratory investigations, confirmed complaints and S1/S2 Field Actions.

• Partner with the site for execution of the site assessment as part of the SHARE program

• Connect with site personnel in context of the compliance awareness (CARE) program

Environment, Health & Safety (EHS)

• Always uses the appropriate prevention rules and procedures

• Uses the available personal and collective protection materials correctly

• Works neat and tidy

• Reports (near) accidents, incidents, deviations and risky situations

• Cooperates on and suggests solutions to improve safety, health an environment

• Participate actively on promotion campaigns, working on the safe behaviour program, prevention controls

• Addresses to other colleagues and third persons when prevention procedures are not followed or in case of unsafe behaviour

Credo

• Takes into account the credo values in all daily activities

• Integrates the Credo dialogue in the IMRC department

Profile needed for this function

Knowledge

• At least 8 years related experience in a GMP-regulated industry and at least 3 years of regulatory compliance experience.

• Extensive knowledge of global GMP regulations is required

• Experience performing internal or external audits is required.

• Ability to build partnerships and mediate issues while optimizing the value proposition.

• Strong analytical skills and ability to clearly articulate issues.

• Excellent communication skills, able to quickly build credibility within the Quality and Compliance community, and executive management.

• Delivers on commitment timelines and has high sense of urgency.

• Demonstrate business acumen, deal with complexity and ambiguity

Degree

Bachelor's Degree in Science or related field

Languages

Fluent in Dutch and English (written and spoken)

Quality: #SCQuality